Status:
RECRUITING
A Study to Learn About the Effects of the Combination of Elranatamab (PF-06863135) and Iberdomide in Patients With Relapsed or Refractory Multiple Myeloma (MagnetisMM-30)
Lead Sponsor:
Pfizer
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The main purpose of the study is to understand how safe and tolerable is elranatamab when given along with iberdomide. There are 2 parts to this study. Part 1 will look at how safe and tolerable is e...
Eligibility Criteria
Inclusion
- Prior diagnosis of multiple myeloma as defined by IMWG criteria
- Measurable disease based on IMWG criteria as defined by at least 1 of the following:
- Serum M-protein ≥0.5 g/dL by SPEP
- Urinary M-protein excretion ≥200 mg/24 hour by UPEP
- Serum immunoglobulin FLC ≥10 mg/dL (≥100 mg/L) AND abnormal serum immunoglobulin kappa to lambda FL ratio (\<0.26 or \>1.65)
- Part 1: Received 2-4 prior lines of therapy for multiple myeloma, consisting of at least 1 immunomodulatory drug and 1 proteasome inhibitor.
- Part 2: Received 1-3 prior lines of therapy for multiple myeloma, consisting of at least 1 immunomodulatory drug and 1 proteasome inhibitor.
- ECOG performance status 0-1
- Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤1
Exclusion
- Plasma cell leukemia, Smoldering multiple myeloma, Waldenström's macroglobulinemia, Amyloidosis, POEMS Syndrome
- Impaired cardiovascular function or clinically significant cardiovascular diseases
- Stem cell transplant within 12 weeks prior to enrollment or active graft vs host disease
- Participants with any active, uncontrolled bacterial, fungal, or viral infection
- Any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ
- Previous treatment with:
- BCMA-directed or CD3 redirecting therapy
- Iberdomide (CC-220) or Mezigdomide
- Administration of strong inhibitor or inducer of CYP3A4/5 within 2 weeks prior to dosing and during the study
- Administration with an investigational product within 30 days preceding the first dose of study intervention
- Participant is unable or unwilling to undergo protocol required thromboembolism prophylaxis
Key Trial Info
Start Date :
February 20 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 9 2028
Estimated Enrollment :
87 Patients enrolled
Trial Details
Trial ID
NCT06215118
Start Date
February 20 2024
End Date
March 9 2028
Last Update
December 18 2025
Active Locations (37)
Enter a location and click search to find clinical trials sorted by distance.
1
Emory University Hospital Midtown
Atlanta, Georgia, United States, 30308
2
Emory University Hospital
Atlanta, Georgia, United States, 30322
3
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States, 30322
4
Winship Cancer Institute
Atlanta, Georgia, United States, 30322